Senior Quality Control Associate - Chemist

At Novartis, we aim to change the practice of medicine, and innovation not only means developing effective, targeted medicines quickly, but also ensuring that these medicines get to the patients who need them. Our vision is to be a trusted leader in changing the practice of medicine. To achieve that, we are continuously seeking talented individuals who are passionate about making a difference in healthcare to be a part our team!

We are currently looking for a Senior Quality Control Associate - Chemist for our San Carlos, CA site.

The Senior Quality Control Associate – Chemist will be a key member of our Quality Control Team. This person will provide technical expertise on analytical testing to include in-process, product release, and stability testing on finished products and APIs, troubleshooting test method validations, and data trending. Additionally, this person will provide coaching and mentoring to staff members while promoting continuous improvements within the lab.

Major accountabilities:• Conduct analytical testing on products and APIs following established SOPs and GMP requirements using HPLC and other analytical instruments.• Review and approve analytical test results for product release and Stability studies.• Troubleshoot and investigate any routine and non-routine technical problems.• Participate in method validation, transfer process, and equipment validation.• Prioritize, schedule, and allocate resources appropriately to ensure efficient workflow, meet production schedules, and full synchronization with our Process Unit (PU) group.• Provide training and mentoring to other associates on analytical methods, lab instrumentation operation and troubleshooting, etc. • Act as a lead investigator on laboratory deviations and outside-of-specification results.• Lead and drive QC process improvement projects.• Generate, maintain, and revise test monographs, SOPs, analytical methods and specifications to ensure compliance with regulatory requirements and filings.• Perform QC analytical data trending and analysis using Minitab or similar tools to calculate continuous process verification (CPV) limits.• Author stability reports and other technical writing requests.• Ensure compliance with GMP/HSE regulations, Novartis policies, procedures and standards appropriate for this role.• Champion a Quality Culture and help ensure a safe working environment.

Requirements

• Bachelor’s degree in a Scientific discipline is required. • A minimum of 8 years of related experience with-in an FDA regulated-industry.• Thorough knowledge of analytical principles, methodologies, and techniques; expert user of HPLC.• Auditing and technical report writing experience.• Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations. • Experience in deviation management, change control, validation, working with Health Authorities (Has) on audits, and Annual Product Review (APR) and Product Quality Review (PQR).• Proficiency with Word, Excel, SAP/LIMS, Track-wise, and data trending software such as Minitab or Jump.• Excellent oral, written, interpersonal and leader-ship skills.• Able to work within cross-functional team settings to drive continuous process improvements.• Able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function.• Employees may be required to inspect products or packaging, or any other task where near visual and/or color acuity is necessary. Possess visual acuity no worse than 20/20 uncorrected or correctable to 20/20 with combined eyes.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland.

Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.